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2015 ; 113
(8
): 1140-7
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A randomised, phase II study of nintedanib or sunitinib in previously untreated
patients with advanced renal cell cancer: 3-year results
#MMPMID26448178
Eisen T
; Loembé AB
; Shparyk Y
; MacLeod N
; Jones RJ
; Mazurkiewicz M
; Temple G
; Dressler H
; Bondarenko I
Br J Cancer
2015[Oct]; 113
(8
): 1140-7
PMID26448178
show ga
BACKGROUND: This exploratory study evaluated the safety/efficacy of nintedanib or
sunitinib as first-line therapy in patients with advanced renal cell carcinoma
(RCC). METHODS: Ninety-six patients were randomised (2:1) to either nintedanib
(200 mg twice daily) or sunitinib (50 mg kg(-1) once daily (4 weeks on treatment;
2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months.
P-values reported are descriptive only; the study was not powered for such
comparisons. RESULTS: Progression-free survival at 9 months was comparable
between nintedanib and sunitinib (43.1% vs 45.2%, respectively; P=0.85). Median
PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence
interval (CI): 0.70-1.80; P=0.64). Median overall survival was 20.4 and 21.2
months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54-1.56;
P=0.76). Overall incidence of any grade adverse events (AEs) was comparable
(90.6% vs 93.8%); AEs grade ? 3 were lower with nintedanib than sunitinib (48.4%
vs 59.4%). Nintedanib was associated with lower incidences of some AEs typical of
antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism,
hand-foot syndrome, cardiac disorders and haematological abnormalities.
CONCLUSIONS: In patients with advanced RCC, nintedanib has promising efficacy and
similar tolerability to sunitinib, and a manageable safety profile with fewer
TKI-associated AEs.